FDA BEST Program for Automation of Adverse Event Reporting
Wednesday, March 5, 2025 1:10 PM to 1:30 PM · 20 min. (US/Pacific)
Government Connections Plaza
Data and Information
Information
FDA Center for Biologics Evaluation and Research (CBER) is expanding its pilot program for automated adverse event (AE) reporting. The Biologics Effectiveness and Safety (BEST IM) Initiative enables health systems to use Fast Healthcare Interoperability Resources (FHIR) based electronic phenotypes to report potential AEs through the national eHealth Exchange. The goal is to increase safety of vaccines, blood products, cell and gene therapies, and other biologics.
Sub-Topic Category
Interoperability and Standards
Target Audience
Chief Quality Officer and Chief Clinical Transformation OfficerCIO/CTO/CTIO/Senior ITGovernment or Public Policy Professional
Format
20-Minute Show Floor Session
